Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

NCT ID: NCT00721838

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2016-07-31

Brief Summary

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to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery

Detailed Description

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The dietary and eating behavior outcomes for adolescents who undergo bariatric surgery are virtually unknown. The main trial of the Teen-LABS consortium is not studying dietary intake and eating behavior before and after bariatric surgery. The consortium, however, provides a unique opportunity to investigate these issues in a large and diverse sample through the context of the proposed ancillary study.

Conditions

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Adolescent Obesity Eating Behavior Dietary Intake

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Surgery group

No interventions assigned to this group

2

Control - Lifestyle modification program

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 19 years old or younger
* have a BMI \> 30 kg/m2
* have attained or nearly attained physical maturity and have a history of unsuccessful, organized attempts at weight management.
* must demonstrate reasonable decision making abilities
* must also fit the following criteria: (1) no prior bariatric surgical procedure, (2) no physical illness not due to obesity, and (3) no full-time special education (due to the high reading demand of study participation).
* Participants will be from all racial and ethnic groups and be both male and female.

Exclusion Criteria

* We will not exclude participants from this trial based on health status or medication usage. Instead, we will track medical conditions and medication usage at every assessment point throughout the investigation to assess the possible influence of these variables on changes in weight, dietary intake, and eating behavior.
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

The University of Pennsylvania Weight and Eating Disorder Program

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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U01DK072493

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK072493

Identifier Type: -

Identifier Source: org_study_id

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